Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) — Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further affirming the quality and compliance of its Direct-to-Patient Site for clinical research. The inspection concluded with a No Action Indicated (NAI) categorization recommendation by the inspector, with no objectionable conditions noted and no Form 483 issued.

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role, enrolling 47% of the US study population. The FDA evaluated internal processes, technology platforms, data integrity, patient safety measures, protocol adherence, Principal Investigator oversight, and all associated documentation.

This marks Science 37’s third consecutive successful FDA inspection in less than two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations, with no Form 483s issued, validating the company’s ability to consistently deliver high-quality, regulatory-compliant research across multiple pivotal studies.

“Our team’s consistent track record not only validates the rigor of our model but also demonstrates how direct-to-patient research can expand reach, safeguard patient safety, and deliver data of the highest integrity,” said Dr. Debra Weinstein, Chief Medical Officer at Science 37. “Each FDA inspection underscores the strength of our Direct-to-Patient Site in upholding the highest regulatory standards and validates how we are advancing clinical research with a strong emphasis on quality and compliance.”

Science 37’s Direct-to-Patient Site extends clinical trial reach beyond the geographic limitations of traditional sites by enabling participation directly from patients’ homes. Leveraging nationwide recruitment and 50-state medical licensure, Science 37 provides a comprehensive range of site services, including investigator oversight, research-grade nursing, CRC support, and direct-to-patient logistics. The site facilitates faster enrollment, enhances trial accessibility, and consistently delivers high-quality data across studies of varying complexity.

Science 37 continues to partner with clinical research sponsors seeking to enhance trial accessibility and enrollment. For more information, visit www.science37.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

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